510(k) · Cleared
ClearedDiscovery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Visual Systems · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jun 20, 2014 as substantially equivalent to K003299 (Nidek Co., Ltd., 2001) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jun 20, 2014
- Review
- 266 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K982057 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| −1 | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| 0 (this device) | K133062 | Discovery System | Innovative Visual Systems | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HJO device
- #1 K253834 Visuref 600score 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003299 | Opd-Scan, Models Ark-10000 and Ark-9000Summary page 2…keted predicate devices. Predicate Device Manufacturer 510(k) Number Date Cleared OPD-Scan Nidek Inc. K003299 3/9/01 Slit Lamp BM 900 Haag-Streit K 100202 .3/19/20 10 De… | 2001 |
| * | K100202 | Slit Lamp BO 900, BQ 900, BP900Summary page 2…r Date Cleared OPD-Scan Nidek Inc. K003299 3/9/01 Slit Lamp BM 900 Haag-Streit K 100202 .3/19/20 10 Description of the Device: The Discovery System combines a corneal topographer and an ocular… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K003299.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Discovery System is intended for use in: Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis. The measurement and analysis of corneal curvature (corneal refractive power), cylindrical power, and cylinder axis of the cornea. The device also maps the display of the corneal shape. White-to-white measurements (also called WTW or horizontal corneal diameter).…
Read the full statement (115 words)
The Discovery System is intended for use in:
Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis.
The measurement and analysis of corneal curvature (corneal refractive power), cylindrical power, and cylinder axis of the cornea. The device also maps the display of the corneal shape.
White-to-white measurements (also called WTW or horizontal corneal diameter).
Retro-illumination imaging of the anterior segment of the eye including intraocular lens imaging.
The measurement of pupil diameter.
In the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from -25.0 to +15.0 diopters spherical, and astigmatism from 0.0 to ± 10.0 diopters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133062: Discovery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133062
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026